Medical device companies who wish to market their products in Europe must obtain a CE marking certification by demonstrating their compliance with the appropriate European regulations - legal documents that set out the requirements for medical device compliance in Europe.
The European Union treats compliance regulations very differently from the United States. Throughout Europe, the CE marking is affixed to all sorts of products to certify their compliance with the appropriate regulations. There are regulations for toy safety, low-pressure vessels, machinery, gas appliances, and both medical and in vitro devices. The European Commission designates third-party organizations called "Notified Bodies" that conduct independent compliance audits of medical device companies before issuing them with a CE mark certification.
How Medical Device Companies Benefit From CE Marking Certification
Obtaining a CE marking certification affirms that your medical device complaies with the essential legal requirements set forth in the medical devices regulations (MDR), in vitro diagnostic regulations (IVDR), or active implantable devices directive (whichever applies to your device). The certification allows you to affix the CE marking to your device and makes it legal for you to sell your medical devices across Europe.
The CE marking provides the additional benefit of free movement of your product throughout the 30 member countries of the European Free Trade Area (EFTA). Finally, the CE marking certification means that customs officers throughout the European Economic Area will be able to seize any instances of your product that are found to be non-conforming, providing your customers with an extra layer of protection from adverse quality events.
Follow These Steps To Obtain Your CE Marking Certification
Obtaining a CE marking certification is a straightforward process, but you'll have to invest time and resources in preparing your company for a third-party audit by a notified body. Here are the basic steps for obtaining CE marking certification:
- Determine which EU directives apply to your device.
- Determine the classification of your device.
- Implement a quality management system that is compliant with ISO 13485.
- Prepare a CE marking technical file or design dossier.
- Establish a physical location in Europe, or appoint a European representative for your company.
- Have your QMS and technical file/design dossier audited by a Notified Body, unless exempt.
- Obtain CE marking and ISO 13485 certificates from the Notified Body.
- Prepare a Declaration of Conformity (DoC), stating that your device complies with the appropriate directives.
Greenlight Guru's QMS Software Streamlines Your CE Marking Certification Process
Notified Bodies will assess your QMS to affirm its compliance with ISO 13485, the accepted International Standard for QMS for medical devices. This means you'll need to produce your policies and procedures for quality management, a quality manual explaining how your overall quality system functions, and evidence that the system is being followed throughout your organization.
Greenlight Guru's cloud-based QMS is designed to facilitate the audit process by ensuring that the latest versions of all required documents are organized and available for your Notified Body audit. Greenlight Guru's QMS Software also makes it easy to prepare your technical file or design dossier for review - the content requirements include a description of your device, wiring and circuit diagrams, a list of standards applied, datasheets for critical sub-assemblies, a part list, instruction manual, test reports, and more.
Storing the most important data about your device with Greenlight Guru's QMS Software protects your valuable intellectual property and makes it easy for you to quickly establish conformity with the appropriate directives and earn your CE marking certification.